Generalized Anxiety Disorder
Conditions
Keywords
Generalized anxiety disorder, Jingji-zhengchong, Gamisoyosan, anxiety
Brief summary
In this randomized, double blinded, Parallel-controlled study, the investigators planned to give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of generalized anxiety disorder according to dosage form.
Interventions
DRUGPlacebo
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
DRUGKyungBangn-Gamisoyosan-x-gwarip
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
DRUGKyungBangn Gamisoyosan
AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 20-65 * (Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰ) subjects who meet Structured Clinical Interview for DSM-Ⅳ Axis Ⅰ Disorder, SCID-Ⅰof generalized anxiety disorder
Exclusion criteria
* Currrent or past history of delusions, halucination * Past history of at least one manic episode, hypomanic episode, or mixed episode * Current or past history of alcohol abuse or alcohol dependence history * Taking substances(e.g. antianxiety drugs, antidepressant, antipsychotic drug, steroids, female hormonal drug, L-dopa, digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) which might affect symptoms * Medical conditions(e.g. myocardial infarction,brain tumor, multiple sclerosis, pancreatic disease, hyperthyroidism, hypothyroidism, Addison disease, Cushing disease, rheumarthritis, cancer, CVA, epilepsy, anemia, pituitarium disease, Vit B12 deficiency disease, PMS) that might affect symptoms * Current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure * Pregnancy, lactation, women not using medically accepted means of birth control * Considered not apt to carry out clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Scale(HAM-A) | 8 weeks | The HAM-A (Hamilton Anxiety Scale) is a widely used interview scale that measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory(BDI) | 8 weeks | BDI is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. |
| Symptom Checklist-90-Revised(SCL-90R) | 8 weeks | The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire). It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It is also used in measuring the progress and outcome of psychiatric and psychological treatments or for research purposes. |
| WHO Quality of Life Abbreviated(WHOQOL-BREF) | 8 weeks | Quality of life is used to evaluate the general well-being of individuals and societies. |
| State-Trait Anxiety Inventory(STAI) | 8 weeks | The State-Trait Anxiety Inventory (STAI) was initially conceptualized as a research instrument for the study of anxiety in adults. It is a self-report assessment device which includes separate measures of state and trait anxiety. |
| PSWQ | 8 weeks | The Penn State Worry Questionaire is a 16-item inventory assess worry and anxiety |
| GSES | 8 weeks | The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. |
| RSE | 8 weeks | Rosenberg Self-Esteem Scale is questionnaire that popular lore recognizes just high self-esteem and low self-esteem, the Rosenberg Self-Esteem Scale quantify it in more detail, and feature among the most widely used systems for measuring self-esteem. |
| Heart Rate Variability(HRV) | 8 weeks | Heart rate variability (HRV) is a physiological phenomenon where the time interval between heart beats varies. It is measured by the variation in the beat-to-beat interval. |
Countries
South Korea
Outcome results
None listed